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NCT ID: NCT03770403 Completed - Clinical trials for Generalized Myasthenia Gravis

A Safety and Tolerability Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness.

ADAPT+
Start date: March 1, 2019
Phase: Phase 3
Study type: Interventional

This is a Long-Term, Single-Arm, Open-Label, Multicenter Phase 3 follow-on trial of the ARGX-113-1704 study to evaluate the safety and tolerability of ARGX-113 in patients with gMG. Patients who have completed at least 1 cycle of treatment and at least 1 year of trial ARGX-113-1705 and have started Part B are eligible to enroll in the open-label trial ARGX-113-2002 to receive efgartigimod by SC administration.

NCT ID: NCT03770039 Completed - Clinical trials for Healthy Male Subjects

Single Dose Study With Unlabeled Dose and 14C-labeled Microdose of PF-06700841 in Healthy Male Subjects

Start date: December 10, 2018
Phase: Phase 1
Study type: Interventional

An open-label, fixed sequence, 2-period including a single oral dose 60 mg PF-06700841 with 14C-labeled microtracer in 1st period, and a single oral dose of 60 mg unlabeled PF-06700841 followed by intravenous administration of 14C-labeled microdose of PF-06700841 1 hour after oral dose in period 2 to characterize the absorption, disposition, metabolism and excretion of PF-06700841 and evaluate the absolute bioavailability and fraction absorbed in the GI tract

NCT ID: NCT03769441 Active, not recruiting - Iron-deficiency Clinical Trials

Effect of Ferric Carboxymaltose on Exercise Capacity After Kidney Transplantation

EFFECT-KTx
Start date: August 2, 2019
Phase: Phase 3
Study type: Interventional

Iron deficiency is common in kidney transplant recipients and is associated with impaired exercise tolerance and an unfavourable prognosis. This multicentre double-blind, placebo-controlled randomized controlled clinical trial will allow the investigators to analyse the effects of intravenous iron correction with ferric(III) carboxymaltose on exercise tolerance and other parameters, in comparison to a placebo.

NCT ID: NCT03769181 Terminated - Lymphoma Clinical Trials

A Study of Isatuximab-based Therapy in Participants With Lymphoma

Start date: December 11, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Primary Objectives: Phase 1 -To characterize the safety and tolerability of isatuximab in combination with cemiplimab in participants with relapsed and refractory classic Hodgkin's lymphoma (cHL), diffuse large B-cell lymphoma (DLBCL) or peripheral T-cell lymphoma (PTCL), and to confirm the recommended Phase 2 dose (RP2D). Phase 2 - Cohort A1 (anti-programmed cell death protein 1/ligand 1 [PD-1/PD-L1] naïve cHL): To assess the complete remission (CR) rate of isatuximab in combination with cemiplimab. - Cohort A2 (cHL progressing from PD-1/PD-L1), B (DLBCL) and C (PTCL): To assess the objective response rate (ORR) of isatuximab in combination with cemiplimab. Secondary Objectives: - To evaluate the safety of the RP2D of the combination of isatuximab with cemiplimab. - To evaluate the safety of the combination of isatuximab with cemiplimab and radiotherapy in participants with cHL. - To evaluate the immunogenicity of isatuximab and cemiplimab when given in combination. - To characterize the pharmacokinetic (PK) profile of isatuximab and cemiplimab when given in combination. - To assess overall efficacy of isatuximab in combination with cemiplimab and isatuximab in combination with cemiplimab and radiotherapy.

NCT ID: NCT03768518 Recruiting - Clinical trials for Congenital Hyperinsulinism

GLP-1 Receptor Expression in CHI

GLP-1-CHI
Start date: February 7, 2018
Phase:
Study type: Observational

The primary objective is the in vivo and ex vivo investigation of the expression and distribution of the GLP-1R in the pancreas of CHI patients.

NCT ID: NCT03768089 Completed - Cystic Fibrosis Clinical Trials

Study of VX-121 in Healthy Subjects and in Subjects With Cystic Fibrosis

Start date: March 20, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate safety and tolerability of VX-121 in healthy subjects and in subjects with cystic fibrosis (CF).

NCT ID: NCT03767985 Recruiting - Amblyopia Clinical Trials

Patching or Gaming as Amblyopia Treatment?

Start date: December 18, 2017
Phase: N/A
Study type: Interventional

Amblyopia affects 3% of the children and is caused by strabismus, anisometropia or both. Standard treatment is glasses and patching therapy. From North-America, behavioural training, i.e. dichoptic training, perceptual learning and video gaming, has become increasingly popular to improve visual acuity not only in children but also in adults. In this study we aim to compare the standard occlusion therapy with dichoptic video gaming.

NCT ID: NCT03767686 Terminated - Clinical trials for Aorto-Iliac Atherosclerosis

Covered Endovascular Reconstruction of Aortic Bifurcation (CERAB) for Extensive Aortoiliac Occlusive Disease

Start date: March 23, 2019
Phase:
Study type: Observational

Endovascular treatment is rapidly taking over surgery for aorto-iliac occlusive disease (AOID), also in extensive pathology. This is related to its minimally invasiveness, decreasing the procedural morbidity rate. When the aortic bifurcation was involved in the lesion, the patency rates of kissing stents configurations were often inferior to open repair. In 2013 the Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) technique was introduced in an attempt to improve endovascular treatment results by a more anatomical and physiological reconstruction, with a subsequent improved clinical outcome. This investigator-initiated multicenter trial will prospectively record all data on performed CERAB procedures using the Bentley balloon expandable covered stents (BeGraft Aortic and BeGraft Peripheral) in multiple International sites, in order to gain more robust real-world data on the efficacy of these stent grafts for this indication. Consecutive patients in whom a CERAB will be performed with these particular covered stents in the participating centers. Main study parameters/endpoints: The primary end-point of this study is technical success. Patency rates, peri-procedural morbidity, clinical improvement, quality of life, clinically-driven target vessel revascularization and reintervention-rate will be secondary outcome measures. Overall, patients will be followed for 5 years

NCT ID: NCT03767244 Active, not recruiting - Prostatic Neoplasms Clinical Trials

A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

PROTEUS
Start date: June 11, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if treatment with apalutamide plus androgen deprivation therapy (ADT) before and after radical prostatectomy (RP) with pelvic lymph node dissection (pLND) in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and metastasis-free survival (MFS) as compared to placebo plus ADT.

NCT ID: NCT03767075 Recruiting - Clinical trials for Advanced Solid Tumor

A Modular Multi-Basket Trial to Improve Personalized Medicine in Cancer Patients (Basket of Baskets)

BoB
Start date: December 10, 2018
Phase: Phase 2
Study type: Interventional

The global objective of this Basket of Basket study is to evaluate the antitumor activity of each matched therapies that will be evaluated through the study in small molecularly selected populations. The objective of module 1 wil be to determine the overall response rate (ORR) at 12 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of atezolizumab in each of the arms of the module. All patients in genomically selected populations will receive atezolizumab 1200 mg IV every 3 weeks. The objective of module 2 wil be to determine the overall response rate (ORR) at 16 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of futibatinib in each of the arms of the module. All patients in genomically selected populations will receive will receive futibatinib, 20 mg, once daily (QD) in 28-day cycles. The objective of module 3 wil be to determine the overall response rate (ORR) at 12 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of amivantamab in each of the arms of the module. All patients in genomically selected populations will receive amivantamab 1050 mg intravenously (IV) for body weight < 80 kg and 1400 mg for body weight >= 80 kg mg once weekly in Cycle 1 (with a split dose on Days 1-2) and then every 2 weeks in subsequent cycles (28-day cycles).